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STATEN ISLAND, N.Y. - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a biopharmaceutical company specializing in the development of new antibiotics, has shared new findings on ibezapolstat, an antibiotic candidate for C. difficile Infection (CDI). The recent analyses indicate that ibezapolstat has a beneficial impact on the gut microbiome and possesses favorable pharmacokinetics with low systemic exposure and high colonic concentrations.
The company presented these findings at the International C. difficile Symposium in Bled, Slovenia, on September 17-19, 2024. During the event, Kevin Garey, PharmD, from the University of Houston, highlighted that ibezapolstat preserves beneficial gut bacteria and may offer a predictive marker for CDI recurrence.
Furthermore, Acurx announced the in vitro efficacy of ACX-375 DNA pol IIIC analogues against Anthrax, including strains resistant to ciprofloxacin. This has prompted the planning of an Anthrax bioterrorism development program.
Acurx has reached an agreement with the FDA on the progression to international Phase 3 clinical trials for ibezapolstat and is preparing for regulatory submissions in the European Union, the United Kingdom, Japan, and Canada.
The Phase 3 trials will involve approximately 450 subjects and will assess ibezapolstat's clinical cure rate and its potential to reduce CDI recurrence. The company aims to demonstrate non-inferiority to vancomycin, with further analysis for superiority if non-inferiority is confirmed.
Ibezapolstat is a novel antibiotic that selectively targets Gram-positive bacteria while preserving a healthy gut microbiome. It has received FDA QIDP and Fast-Track Designation, highlighting its potential against CDI, which the CDC considers an urgent threat.
CDI is a significant health care-associated infection, with an estimated 500,000 cases annually in the U.S. and a high recurrence rate. The development of ibezapolstat could offer a new treatment option for this challenging infection.
This report is based on a press release statement from Acurx Pharmaceuticals, Inc.
In other recent news, Acurx Pharmaceuticals is making significant strides with its antibiotic candidate, ibezapolstat. The company reported promising research results, setting the stage for international Phase 3 clinical trials to treat C. difficile Infection (CDI). The research, conducted in collaboration with Leiden University Medical Center, provides crucial insight into the molecular structure of ibezapolstat and its mechanism of action.
Ibezapolstat has demonstrated a lack of cross-resistance with other antibiotics, potentially offering a significant advantage in the fight against antimicrobial resistance. The company has reached an agreement with the FDA on key elements for the upcoming Phase 3 trials and is preparing to request regulatory guidance for clinical trials in multiple regions.
In financial matters, Acurx reported a net loss of $4.1 million for the second quarter of 2024, with a cash reserve of $6.4 million. The company is actively seeking partnerships and non-dilutive funding options to cover the estimated $50 million cost of the Phase 3 trials. Despite the significant net loss, Acurx remains optimistic about its financial sustainability, with funds expected to last until mid-2025 or mid-2026. These recent developments highlight Acurx Pharmaceuticals' strategic approach as it navigates a critical phase in its growth.
InvestingPro Insights
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) has been making strides in antibiotic development, yet the company's financial metrics provide a more comprehensive picture of its current market stance. With a market capitalization of approximately $30.22 million, Acurx is navigating the competitive biopharmaceutical landscape with a focus on innovation. However, the company's valuation tells a story of challenges, as it is trading at a high Price/Book multiple of 8.86, which reflects the market's assessment of its assets relative to the share price. This, paired with a negative P/E ratio of -1.62, indicates that Acurx is not currently profitable, a point underscored by the fact that analysts do not expect the company to be profitable within this fiscal year.
InvestingPro Tips suggest that while Acurx holds more cash than debt on its balance sheet, which is a positive sign of financial health, the stock has recently experienced a significant decline, with a one-week total price return of -8.33%. This volatility is further emphasized by the stock's tendency to move inversely to market trends. Moreover, the company's gross profit margins are considered weak, and it does not pay dividends to shareholders, potentially affecting its attractiveness to income-focused investors.
For investors looking for deeper insights into Acurx Pharmaceuticals, there are additional InvestingPro Tips available, offering a more granular look into the company's financial health and market performance. These tips can be accessed through InvestingPro's platform and may provide valuable guidance for those considering an investment in the biopharmaceutical sector.
As Acurx Pharmaceuticals continues to progress through clinical trials and regulatory submissions, these financial metrics and InvestingPro Tips will be crucial for investors to monitor, providing a window into the company's potential for long-term growth and stability in a rapidly evolving industry.
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